Information  X 
Enter a valid email address
  Print      Mail a friend       More announcements

Tuesday 30 October, 2007

Helsinn Healthcare SA

Helsinn Healthcare and MGI PHARMA Announce Subm...





LUGANO, Switzerland, October 30 /PRNewswire/ --

    - Oral Formulations of 5-HT3 receptor Antagonists Represent Approximately 
10% of the Day-of-Chemotherapy Market.



    Helsinn Healthcare SA, a privately owned Swiss pharmaceutical group, and
its partner MGI PHARMA, INC., (Nasdaq: MOGN), a biopharmaceutical company
focused in oncology and acute care, today announced that a supplemental New
Drug Application (sNDA) for Aloxi(R)(palonosetron hydrochloride) Capsules for
oral administration has been submitted to the U.S. Food and Drug
Administration (FDA). Aloxi Injection is approved by the FDA for the
prevention of acute nausea and vomiting associated with initial and repeat
courses of moderately and highly emetogenic cancer chemotherapy and for the
prevention of delayed nausea and vomiting associated with initial and repeat
courses of moderately emetogenic cancer chemotherapy.



    The sNDA submission includes results from a multicenter, double-blind,
dose ranging trial in 651 patients receiving moderately emetogenic
chemotherapy (MEC). Patients were stratified by gender and history of
chemotherapy and were randomly assigned to receive one of three doses of oral
Aloxi (0.25 mg, 0.50 mg, or 0.75 mg) or a single intravenous (IV) 0.25 mg
dose of Aloxi. The primary objective of the study was to determine an oral
dose which was non-inferior to the IV 0.25 mg dose of Aloxi. Endpoints of the
trial included complete response (CR; no emesis, no rescue therapy) at
multiple time intervals.



    Overall, results of the study indicate that the 0.50 mg oral dose of
Aloxi was non-inferior to the 0.25 mg IV dose at inducing a CR during both
the early (0-24 hr) and delayed phases (0-48, 0-72, 0-120 hr) following
administration of MEC. Specifically, CR rates for the 0.50 mg dose of oral
Aloxi were 76.3% and 58.8% for the 0-24 hours and 0-120 hours time periods
versus 70.4% and 59.3% for the 0.25 mg IV dose of Aloxi, respectively.



    Adverse events were similar in nature and rate for the oral and IV Aloxi
groups and typical for this class of drug (headache and constipation).
Results from this trial were presented on September 26, 2007, at the 14th
European Cancer Conference.



    "Helsinn is extremely pleased with this submission as it represents an
important step in broadening the Aloxi franchise," said Dr. Sergio
Cantoreggi, Senior Director, Research & Development of HELSINN HEALTHCARE SA.
"We believe an oral formulation of Aloxi may offer important benefits to the
medical community and cancer patients."



    "The submission of the sNDA for an oral formulation of Aloxi represents
another key milestone in the efforts of Helsinn Healthcare and MGI to seek
indications that expand the Aloxi label and accelerate the growth of the
Aloxi franchise," said Mary Lynne Hedley, Executive Vice President and Chief
Scientific Officer of MGI PHARMA. "We believe Aloxi's unique pharmacodynamic
profile and long-lasting activity would be desirable in clinical settings
where an oral formulation may be preferred."



About Aloxi(R)(palonosetron hydrochloride) Injection

    Aloxi is approved by the U.S. FDA for the prevention of acute nausea and
vomiting associated with initial and repeat courses of moderately and highly
emetogenic cancer chemotherapy and for the prevention of delayed nausea and
vomiting associated with initial and repeat courses of moderately emetogenic
cancer chemotherapy. Aloxi is the first and only 5-HT3 receptor antagonist to
be indicated for the prevention of delayed CINV caused by moderately
emetogenic cancer chemotherapy. The most common adverse reactions related to
Aloxi were headache (9%) and constipation (5%). Aloxi is contraindicated in
patients known to have hypersensitivity to the drug or any of its components.
Please see the Aloxi package insert, available at www.mgipharma.com and
http://www.aloxi.com, for important additional details.



About MGI PHARMA

    MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and
acute care that acquires, researches, develops, and commercializes
proprietary products that address the unmet needs of



    patients. MGI PHARMA markets Aloxi(R)(palonosetron hydrochloride)
Injection, Dacogen(R)(decitabine) for Injection, and Gliadel(R)Wafer
(polifeprosan 20 with carmustine implant) in the United States. The Company
directly markets its products in the U.S. and collaborates with partners to
reach international markets. For more information about MGI PHARMA, please
visit http://www.mgipharma.com.



About Helsinn Healthcare

    Helsinn Healthcare SA, a privately owned pharmaceutical group with
headquarters in Switzerland, is the worldwide licensor of palonosetron.
Helsinn's core business is the licensing of pharmaceuticals in therapeutic
niche areas. The company's business strategy is to in-license early stage new
chemical entities and complete their development from the performance of
pre-clinical/clinical studies and CMC development to the attainment of market
approvals in strategic markets (U.S. and Europe). Helsinn's products are
out-licensed to its marketing partners for distribution. The active
pharmaceutical ingredients and the finished dosage forms are manufactured at
Helsin's cGMP facilities and supplied worldwide to its customers. For more
information about Helsin, please visit the company's Web site at
http://www.helsinn.com



    
    Contact

    Helsinn Healtcare SA
    Paolo Ferrari
    Head of Marketing - Oncology and Supportive Care
    Tel: +41-91-985-21-21
    E-Mail: [email protected]

    MGI PHARMA
    Timothy J. Smith
    Tel: +1-952-406-3100
    E-Mail: [email protected]


                                                                                                                                                               

a d v e r t i s e m e n t